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Plenary session at AANS underscores REYOBIQ’s potential as a differentiated targeted radiotherapeutic platform for CNS cancers

HOUSTON, Texas, May 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announces a plenary session reviewing key clinical and translational data, including the Phase 1 ReSPECT-LM trial of REYOBIQ™ (rhenium Re186 obisbemeda) was presented at the 2026 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting taking place May 1-4, 2026 in San Antonio, Texas.

“This oral plenary session, which reviewed data collected to date, and included an overview of the ReSPECT-LM single dose escalation study, is an important validation of the clinical and translational evidence supporting REYOBIQ as a differentiated therapeutic approach for patients with leptomeningeal metastases, a devastating condition with no FDA-approved therapies. AANS is an important congress, and we are encouraged by these data being featured in such a prominent part of the conference,” said Eric J. Daniels, M.D., M.B.A., Plus Therapeutics Chief Development Officer. “We continue to believe strongly in the potential of REYOBIQ in the clinical setting as we continue the ongoing multiple dose trial.”

The oral presentation, titled, “¹⁸⁶Rhenium-Nanoliposomes (¹⁸⁶RNL) for the Treatment of Leptomeningeal Metastases: Translational Insights from Clinical and Preclinical Models,” was delivered by Henriette U. Balinda, PhD, of UT Health San Antonio in a Plenary Session on Saturday, May 2, 2026.

Key Data Highlights

The Presentation highlighted the completed Phase 1 ReSPECT-LM study demonstrating:

Encouraging survival outcomes, with median overall survival of approximately 9 months in patients treated at the recommended Phase 2 dose, compared to historical survival of approximately 2–6 months

Robust anti-tumor activity, including high rates of circulating tumor cell (CTC) reduction and clinical benefit across evaluable patients

Favorable safety and tolerability profile, supporting advancement into later-stage clinical development
Highly targeted radiation delivery, with a target-to-off-target absorbed dose ratio exceeding 100:1, minimizing exposure to healthy tissue

In addition, translational analyses presented in the session demonstrate that REYOBIQ may induce immune remodeling within the tumor microenvironment, including activation of CD8+ T cells and enhancement of anti-tumor immune response, supporting potential future combination strategies with immunotherapies.

Currently, the ReSPECT-LM Phase 1 Multiple Dose trial is underway and enrolling patients at the University of Texas Health San Antonio. The primary objectives include characterizing safety and tolerability of multiple doses at defined intervals of REYOBIQ for patients of any primary solid tumor cancer with LM.

Enables billing under traditional Medicare and creates a pathway to ~35 million Medicare Advantage beneficiaries through future payer coverage decisions
HOUSTON, May 07, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announced that its wholly owned subsidiary, CNSide Diagnostics, LLC (“CNSide Diagnostics”), has successfully enrolled in the Medicare program and received a Provider Transaction Access Number (PTAN) from the Centers for Medicare & Medicaid Services (CMS).

This key milestone establishes CNSide Diagnostics as a Medicare-enrolled clinical laboratory, enabling the submission of claims for its CNSide® Cerebrospinal Fluid (CSF) Assay Platform, including the tumor cell enumeration (TCE) test. Claims will be reimbursed when determined to be reasonable and necessary by the Medicare Administrative Contractor (MAC) with jurisdiction over the laboratory.

“Medicare enrollment represents a critical step in our commercialization strategy,” said Russ Havranek, EVP Corporate and Commercial Strategy. “It enables access to approximately half of the U.S. Medicare population through Traditional Medicare, subject to coverage determinations, while establishing a clear pathway to expand into Medicare Advantage populations over time. Combined with our existing ~81 million commercial covered lives, this milestone strengthens our pathway to broader patient access, adoption, and revenue growth.”

Strategic and Commercial Impact
Expanded Billing of Traditional Medicare: Enables billing for testing furnished to Medicare Fee-For-Service beneficiaries, subject to coverage determination by our local Medicare Administrative Contractor (MAC)

Pathway to Medicare Advantage: Positions CNSide Diagnostics to pursue coverage with Medicare Advantage plans, including those administered by United Healthcare, Humana, Highmark, Blue Shield of California, and other national and regional payers

Accelerates Coverage and Pricing Efforts: Enables active engagement with MACs to pursue local coverage determinations (LCDs) and supports CMS pricing determinations under the Clinical Laboratory Fee Schedule (CLFS)

Medicaid Momentum: Provides essential credentialing for state-by-state Medicaid enrollment

Next Steps: Reimbursement Momentum
With Medicare enrollment secured, CNSide Diagnostics is focused on the following near-term milestones:

Medicare Coverage Pathway — Engagement with MACs to secure formal coverage determinations

CLFS Pricing — Establishment of a payment rate for the new CPT code 0640U (CNSide CSF TCE Test), effective for billing July 1, 2026, via crosswalk or gapfill methodology

Further Commercial Expansion — Continued execution of national and regional payer contracts toward the 2026 goal of 150 million+ covered lives

Positioning CNSide Diagnostics for Scaled Adoption
The CNSide® CSF Assay Platform is a novel diagnostic tool that detects and characterizes tumor cells and circulating tumor DNA in cerebrospinal fluid. It enables earlier and more accurate diagnosis, disease monitoring, and treatment decision-making for patients with leptomeningeal metastases — a devastating complication of CNS cancers where conventional methods like MRI and cytology frequently fall short.

With Medicare enrollment now complete, CNSide Diagnostics is executing a focused commercialization strategy to drive broad clinical adoption:

Payer Coverage Expansion: Building on the current 81 million commercial covered lives to further broaden access through additional national and regional payer contracts
Clinical Utility & Health Economics: Generating robust real-world data to demonstrate improved patient outcomes and cost-effectiveness

Key Account Engagement: Deepening relationships with leading academic medical centers and community oncology networks

Reimbursement Optimization: Refining coding, billing, and collections processes to maximize efficiency and revenue capture

Expands access by 6 million covered lives, advancing commercial momentum for CNSide® in metastatic CNS cancers

HOUSTON, April 28, 2026 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), announced today a new payer coverage agreement with Blue Shield of California, effective April 2026, providing reimbursement for its CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) assay for patients with metastatic central nervous system cancers. Blue Shield of California joins a growing list of national and regional payers, including United Healthcare, Humana, and Highmark, that provide coverage for CNSide.

The addition of Blue Shield of California expands CNSide’s total covered lives from approximately 75 million to 81 million, representing continued progress toward the Company’s 2026 objective of 150 million covered lives, while expanding patient access across the U.S. The agreement is expected to further accelerate adoption of CNSide across oncology centers by reducing reimbursement barriers.

“This agreement with Blue Shield of California represents another important step in expanding payer coverage and access to CNSide for patients with leptomeningeal metastases,” said Russ Havranek, EVP Corporate and Commercial Strategy at Plus Therapeutics. “We continue to execute on our strategy to broaden reimbursement, support physician adoption, and improve outcomes for patients with difficult-to-diagnose CNS cancers.”

The CNSide® CSF Assay Platform enables earlier, and more accurate detection and monitoring of leptomeningeal metastases compared to conventional CSF cytology, supporting rapid diagnosis, treatment monitoring, and treatment guidance. The superior clinical utility of CNSide® over standard of care has been demonstrated in nine peer-reviewed publications, the FORESEE clinical trial, and demonstrated in real-world practice. Earlier detection enabled by CNSide has been shown in health economic analyses to reduce overall leptomeningeal metastases-related healthcare costs by ~40%, driven by earlier detection and treatment optimization.

Since its commercial launch, more than 11,000 CNSide tests have been performed at over 120 U.S. cancer institutions since 2020, delivering high sensitivity (92%) and specificity (95%), while influencing treatment decisions in 90% of cases.

This test is available exclusively through CNSide Diagnostics, LLC. as a testing service provided to health care professionals in the U.S.